The Bloom #141 Free Edition PsyPal, not PayPal

You blink twice, and it's February.

The past January brought great news for us Europeans, marking the launch of the PsyPal trial, a research effort spanning nine countries and funded up to the tune of €6.5 million. The research, investigating psilocybin-AT for end-of-life anxiety/depression is the first to do so outside of the scope of cancer. The funding, coming from Horizon Europe, will allow over 100 participants to join the study.

Speaking of 100+, that is easily the number of studies published last month. Of those, I've summarized and analysed the 25 most interesting articles, which are now available in the January recap.

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ps Learn about how GMP psychedelics are made by experts Dr. Preston A. Chase & Karina Lahnakoski during a live webinar on the 13th of February at 2 pm PST. Register for a front-row and behind-the-scenes look at the current and future state of GMP psychedelic manufacturing.​

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Latest Psychedelic Research

1 Assessing expectancy and suggestibility in a trial of escitalopram v. psilocybin for depression​

This reanalysis of an RCT (n=55) compared escitalopram and psilocybin (COMP360) for treating depression (MDD). Patients had higher expectancy for psilocybin, but only expectancy for escitalopram predicted therapeutic outcomes. Additionally, pre-treatment trait suggestibility was associated with therapeutic response in the psilocybin arm, suggesting psychedelic therapy may be less vulnerable to expectancy biases, and highly suggestible individuals may be primed for response to psilocybin treatment.

2 Safety, tolerability, pharmacodynamic and wellbeing effects of SPL026 (dimethyltryptamine fumarate) in healthy participants​

This Phase I study (n=44) investigates the safety, tolerability, pharmacokinetics, and -dynamic profile of escalating doses of SPL026 (DMT fumarate; 9-21.5mg) in psychedelic-naïve healthy participants. The RCT concludes that SPL026 was well-tolerated, showing an acceptable safety profile, with potential correlations between plasma concentration and psychometric measures.

3 MDMA enhances positive affective responses to social feedback​

This double-blind, placebo-controlled crossover trial (n=36) investigates the effects of two doses of MDMA (52.5-105mg/70kg) compared to both placebo and methamphetamine (20 mg) on responses to personalized social feedback in healthy adults. The study concludes that the higher dose of MDMA increases positive affective responses to social feedback, suggesting a potential mechanism by which MDMA may enhance social connection.

More new research

• ​Novel Benzofuran Derivatives Induce Monoamine Release and Substitute for the Discriminative Stimulus Effects of 3,4-Methylenedioxymethamphetamine​
• ​DMT induces a transient destabilization of whole-brain dynamics​
• ​Neural complexity is increased after low doses of LSD, but not moderate to high doses of oral THC or methamphetamine​
• ​Microdosing psychedelics: Current evidence from controlled studies​
• ​A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review​
• ​Older adults in psychedelic-assisted therapy trials: A systematic review​
• ​Serotonin-2 Receptor Agonists Produce Anti-inflammatory Effects through Functionally Selective Mechanisms That Involve the Suppression of Disease-Induced Arginase 1 Expression​

New on Blossom

1 Psychedelic Research Recap January 2024​

January saw new psychedelic trials on ibogaine for TBI, DMT, and psilocybin for CCHs, alongside re-analyses on psychedelic brain impacts, therapy dynamics in MDMA treatment, and LSD visuals. Studies also probed SSRI-psychedelic interactions, expectancy roles, and heart effects from microdosing.

2 Psychedelic Research Links 2024​

All the other papers that have come out this year that don't have a separate entry in the database.

Spotlight

1 Know Your Psychedelic Drug Candidate (Event)

Join Optimi Health's webinar on Feb 13, 2024, at 2 PM PST to delve into GMP psychedelic drug standards with experts Dr. Preston A. Chase & Karina Lahnakoski. Learn about safe, quality psychedelic therapy production and its future.

Are you a clinician, researcher, therapist, pharmacist, or regulator?

Are you currently researching the safety and efficacy of psychedelics in a clinical trial?

Are you currently treating patients through a regulated compassionate access program?

Are you wanting to learn more about the cultivation and formulation of true end-to-end GMP psychedelics?

If you answered yes to any of these questions, then please join Optimi Health Chief Science Officer, Dr. Preston A. Chase, and Director of Quality Commercial Strategies, Karina Lahnakoski, as they provide a rare glimpse into the commercial manufacturing and formulation of Optimi's GMP psychedelic drug candidates.

2 European Union funds groundbreaking research into psychedelic therapy (News)

The European Union has granted over €6.5 million to fund the PsyPal study, a pioneering research initiative coordinated by the University Medical Center Groningen, investigating the use of psilocybin therapy for psychological distress in patients with incurable diseases like COPD, MS, ALS, and Parkinson's.

This marks the EU's first foray into financing clinical trials on psychedelic-assisted therapy. Commencing in early 2024, the study will involve over a hundred patients across Europe, aiming to determine the safety and long-term effects of psilocybin.

This effort is part of Horizon Europe's mission to promote innovative research and is a collaborative venture involving 19 organizations from 9 countries, seeking transformative treatments for challenging psychological conditions.

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